MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I ANTI-HCV REAGENT KIT; ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS

Catalog Number 08P06-74

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

There was no further patient information provided by the customer.This report is being filed on an international product, list number 8p06 that has a similar product distributed in the us, list number 8p05.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false nonreactive alinity i anti-hcv results on one patient when using different lot number of reagents.The results provided were: anti-hcv results using lot number 14467be00 on alinity ai03718=1.19 s/co (>or=1.00 s/co=reactive)/repeated on alinity ai03119 =1.21 s/co and 1.26 s/co.Anti-hcv result using lot number 18312be00 on alinity ai03718=0.4 s/co, and 0.37 s/co (<1.00 s/co=nonreactive)/, repeated on alinity ai03119 =0.35 s/co and 0.36 s/co.There was no reported impact to patient management.

Manufacturer Narrative

A search of complaints for alinity i anti-hcv assay, lot 18312be01 identified no similar complaints and no trends for the customer's issue.An investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of the manufacturing documentation, review of field data, device history record and a review of product labeling.This review did not find any abnormal complaint activity and no trends were identified.Return testing was not completed as returns were not available.A retained reagent kit of lot number 18312be01 was tested in a sensitivity setup and results of this setup did not implicate that the performance of the lot was negatively impacted.Testing includes additional replicates of the positive control and two commercially available seroconversion panels (zeptometrix hcv seroconversion panels hcv 9047 and hcv 9045).All specifications were met indicating the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customers observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i anti-hcv assay, lot number 18312be01.Updated information section d4: updated lot number to 18312be01 from 18312be00 and catalog number to 08p06-74 to 08p06-22.

• Brand Name: ALINITY I ANTI-HCV REAGENT KIT
• Type of Device: ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10720644
• MDR Text Key: 214800817
• Report Number: 3002809144-2020-01036
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2021
• Device Catalogue Number: 08P06-74
• Device Lot Number: 18312BE01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI03119; ALNTY I PROCESSING MODU, 03R65-01, AI03119